320
Participants
Start Date
March 28, 2024
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2026
Videodensitometric guided
"In the experimental arm, a TAVI device is implanted according to the local practice. Immediately after implantation, aortography is performed to quantitatively assess the aortic regurgitation (qAR). The aortography is analyzed using CAAS A-Valve (Pie-Medical, Maastricht, The Netherlands).~•If qAR is \>17%, we recommend that corrective post-TAVI manoeuvres (post-dilatation, valve-in-valve, etc.) will be performed and angiography is repeated for the assessment of aortic regurgitation. If the qAR ≤17%, whether corrective post-TAVI manoeuvres (post-dilatation, valve-in-valve, etc.) will be performed is left to the discretion of the operators. Inform operators of the results of qAR and the threshold criteria. Continuous qAR was stratified into categorical variables according to the following pre-determined threshold criteria: (1) none or trace (qAR \<6%); (2) mild (6% to ≤17%); and (3) moderate or severe (\>17%).~At discharge, all the patients will undergo Cardiac magnetic resonance, the Car"
Stand of care guided
"In the control arm, a TAVI device is implanted according to local practice. Immediately after implantation, TEE/TTE or aortography is performed as a part of usual practice.~* The requirement of post-dilatation or any additional procedure is left to the discretion of the operator.~* The operator judges the sufficient procedural outcome to end the procedure according to local practice.~At discharge, all the patients will undergo Cardiac magnetic resonance, the Cardiac magnetic resonance-derived regurgitation fraction (CMR-RF) will be analyzed as the primary endpoint."
Xijing hospital, Xi'an
Zhongshan hospital, Fudan University, Shanghai
Xijing Hospital
OTHER